FDA.reportPublic FDA data

0.8 ML adalimumab-aacf 50 MG/ML Injection

RxCUI
2699315
RxNorm name
0.8 ML adalimumab-aacf 50 MG/ML Injection
Display name
0.8 ML adalimumab-aacf 50 MG/ML Injection
Full name
0.8 ML adalimumab-aacf 50 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761255Idacioadalimumab-aacf351(k) BiosimilarRx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IDACIOADALIMUMAB-AACFFresenius Kabi USA, LLC08dbaffe-9d05-43cf-b24b-b44ade8685fc2024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2699315

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
08dbaffe-9d05-43cf-b24b-b44ade8685fc0.8 ML adalimumab-aacf 50 MG/ML InjectionSCD1These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO . IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful 20241015
08dbaffe-9d05-43cf-b24b-b44ade8685fcadalimumab-aacf 40 MG in 0.8 ML InjectionPSN1These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO . IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful 20241015
08dbaffe-9d05-43cf-b24b-b44ade8685fcadalimumab-aacf 40 MG per 0.8 ML InjectionSY1These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO . IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful 20241015